There is an astounding paucity of research on the efficacy and safety of botanical therapies used for the treatment of HIV / AIDS. Two comprehensive reviews of the literature were identified, one by Mills et al. on complementary and alternative medicine therapies and one by the Cochrane Collaboration specifically on botanical therapies. Mills et al. only identified three botanical trials that met their inclusion criteria. Two of the trials were of Chinese herbal preparations, the other of an extract of the boxwood plant (Buxus sempervirens). Another trial looked at the effectiveness of capsicum on AIDS-related peripheral neuropathy.
The Cochrane Collaboration review identified a total of nine randomized placebo-controlled clinical trials, involving 499 individuals with HIV or AIDS, which met their inclusion criteria. A total of eight different herbal medicines were evaluated in these trials. Herbal medicines were defined as preparations derived from plants, and could be extracts from a single herb or a compound of herbs. It should be noted that these are generally not herbal products that one can simply purchase at a natural foods store or obtain through a local herbalist. They are often more closely akin to pharmaceutical products. These were compared with no intervention, placebo, and antiretroviral therapies. Outcome measures included mortality, HIV progression, new AIDS-defining event, number and types of adverse events, immunologic indicators (CD4 and white blood cell counts), viral load, and psychological status and quality of life. With limited exception (e.g., diarrhea), most of these trials looked at herbs and HIV / AIDS directly, rather than at supportive therapies for specific symptoms or associated problems, such as ginger for nausea or marijuana for appetite stimulation. Several trials are committed from the presentation below due to lack of efficacy or side effects, thus leaving a total of four trials that demonstrated efficacy and a lack of significant side effects compared to placebo.
IGM-1 (Chinese Herb Combination)
In a 1996 study by Burack et al., 30 patients with at least two HIV-related symptoms were randomly assigned to receive herbs (n = 15) or placebo (n = 15). The product, IGM-1, is a standardized preparation of 31 Chinese herbs developed by one of the investigators. Of 31 herbal ingredients in the 650-mg tablet, those present in high concentration included Ganoderma lucidum, Isatis tinctoria, Astragalus membranaceus, Andrographis paniculata, Lonicera japonica, Milletia retkulata, Oldenlandia diffusa, and Laminaria japonica. Overall life satisfaction appeared to be improved in patients treated with herbs compared with placebo. Patients receiving herbs reported a reduced number of symptoms. There was no significant reported difference in overall health perception, symptom severity, absolute CD4 count, anxiety or depression between the two groups. No adverse events were reported or identified in any of the patients randomized to herbs.
“35” Chinese Herb Combination
In a 1999 study by Weber et al., HIV-infected adults (n = 68) were randomized to receive a preparation of 35 Chinese herbs (n = 34) or placebo (n = 34). The preparation includes Ganoderma lucidum, Isatis tinctoria, Milletia reticulata, Astragalus membranaceus, Tremella fuciformis, Andrographis paniculata, Lonicera japonica, Aquilaria agallo-cha, Epimedium macranthum, Oldenladia diffusa, Cistanche salsa, Lycium chinense fructus, Laminaria japonica, Angelica sinensis, Polygonum cuspidatum, Panax quinquefolium, Schizandra chinensis, Ligustrum lucidum, Atractylodes macrocephala, Rehmannia glutinosa, Salvia miltiorrhiza, Curcuma longa, Viola yedonensis, Citrus reticulata, Paeonia lactiflora, Polygonum multiflorum, Eucommia ulmoides, Amomum villosum, Glycyrrhiza uralensis, Prunella vulgaris, Cordyceps sinensis, Pogostemum cablin, Crataegus cuneata, Massa medica fermentata, Hordeum vulgare, and Oryza sativa. Of those completing the study (24 in the herb group and 29 in the placebo group), there were no significant differences in CD4 cell counts and HIV-1 RNA load. There were no significant differences between the groups regarding new AIDS-defining events, number of reported symptoms, psychosocial measurements, or quality of life. There were more adverse effects in the herb group (19 / 24) than in the placebo group (11 / 29). Adverse events included diarrhea, increased number of daily bowel movements, abdominal pain, constipation, flatulence, and nausea. There was no evidence of toxicity from the study drugs, based on hematologic and blood chemistry analysis. The deaths of two patients in the herb group were attributed to severe immunodeficiency and pre-enrollment history of multiple severe opportunistic complications and not to the herbal preparation.
In a pilot trial in France, 43 asymptomatic HIV patients with CD4 cell counts between 250 and 500 / mm were divided into an SPV30 (n = 22) or placebo (n = 21) group. Patients receiving SPV30 were less likely to progress to AIDS-related complications or to decrease to a CD4 cell count of below 200 / mm. There was a significant increase of CD4 cell count in people treated by SPV30 after 30 weeks compared with placebo. Based on these findings, 145 previously untreated participants with asymptomatic HIV infection and decreased CD4 cell count (250 to 500 / mm) were randomized to SPV30 990 mg / day (n = 48), SPV30 1980 mg / day (n = 49), or placebo (n = 48). There was a tendency for AIDS defining events such as candidiasis, herpes zoster, weight loss, and diarrhea to occur less frequently in the SPV30 group (combination of two dosages) than in the placebo group (RR 0.12, 95% CI 0.01 to 1.08; p = 0.06). There was no significant difference between either SPV30 990 mg / day or SPV30 1980 mg / day and placebo with respect to CD4 cell counts and viral load. The trial did not observe serious adverse effects, and biochemical parameters did not show abnormal changes in the participants.
SP-303 is a product containing a proanthocyanidin oligo-mer isolated and purified from the latex of Croton lechleri. Fifty-one patients with AIDS and diarrhea were randomized to either SP-303 or placebo. SP-303 reduced stool weight and abnormal stool frequency. The product was well tolerated and there were no adverse events reported in either group.
The authors of the Cochrane review concluded that there is insufficient evidence to support the use of herbal medicines in HIV-infected individuals and AIDS patients. It must be remembered that only a very few of the large number of herbs that are used for HIV / AIDS have been subject to any evaluation.